Sterile packaging of medical devices has been extensively developed. These devices may encompass a broad range of products, such as syringes, needles, bandages, catheters and many others. Particular sterile care must be undertaken with regard to the use of catheters intended to be inserted through body openings. When a catheter is employed to aid in urethral catherization, precautions need to be taken to avoid introduction of infection carrying bacteria. Since such catherization is for some people the only available technique to void their urine, self-catheterization devices and techniques would be particularly useful for active persons as compared to otherwise in-dwelling type catheter devices. See, for example, an article entitled "Experience With Non-Sterile, Intermittent Self-Catheterization" by Orikasa et al, published at page 141 in Volume 115 of the February 1976 issue of The Journal of Urology by the Williams & Wilkins Co. Another article related to self-catheterization was published in The Journal of Urology, Vol. 107, March 1972, page 458, by Lapides et al, under the title "Clean Intermittent Self-Catheterization In The Treatment Of Urinary Tract Disease".
As described in the first article, a patient carries a catheter which, before use, is washed and occasionally sterilized by boiling. The patient employs the catheter a number of times on a daily basis, thereby improving comfort and correcting physiological conditions. However, sterility is not always maintained. In order to take advantage of the intermittent self-catheterization procedure, the use of disposable sterile catheters in a sterile manner would enhance the benefit of such self-catheterization procedure.
Sterile packages of catheters for use in their subsequent sterile handling are well known in the art. For example, in the U.S. Pat. No. 4,140,127 to Cianci et al, a package encloses a sterile catheter assembly formed of an elongated flexible sleeve having a folded back cuff which surrounds the distal tip of a urethral catheter. Upon opening of the package to break the sterile barrier, one can grip the catheter at its distal end through the sleeve and under the cuff for sterile handling. A disadvantage of the Cianci et al package is that the catheter is not continuously gripped from the time that the sterile barrier is broken so that inadvertent contamination of the catheter distal tip may occur.
In U.S. Pat. No. 3,930,580 to Bazell et al, a sterile catheter package is taught wherein a catheter is placed in a pouch formed between two sheets which are joined at separable edges. The catheter is removable by separating one sheet from another along tear zones located at opposite edges of the sheets. A tab is connected to one sheet so that one may, by holding the tab in one hand, on one side of a score line while holding the package on the other side of the score line with the other hand, pull the sheets apart.
In the U.S. Pat. No. 3,934,721 to Juster et al, a sterile catheter package is shown wherein a catheter package is located within an overpackage. U.S. Pat. No. 3,926,309 to Center shows a multicompartmented sterile catheter package and U.S. Pat. Nos. 3,683,928 to Kuntz and 3,898,993 to Taniguchi show sterile catheter packages with catheter lubricants. U.S. Pat. No. 2,856,932 to Griffits teaches the attachment of a sterile packaged urethral catheter attached to a bag in which urine may be collected.
While these sterile catheter packages may be useful for the removal and use of the catheters, they may be cumbersome to use and particularly difficult to keep a catheter uncontaminated for a self-catheterization procedure.